1. Field of the Invention.
This invention relates, generally, to medical devices. More particularly, the invention relates to hemostatic devices used for arresting the flow of blood or hemorrhage from punctures of the vascular system.
2. Background Information.
Various surgical procedures are performed by medical specialists such as cardiologists and radiologists utilizing percutaneous entry into a blood vessel or body cavity. Examples of such procedures include different techniques to recanalize atherosclerotic blood vessels, such as balloon angioplasty or atherectomy. Recently, both the types and number of procedures performed utilizing the above mentioned percutaneous access to blood vessels have increased greatly.
These procedures generally involve the percutaneous puncture with a thin walled needle into a blood vessel. Following this, a guidewire is placed through the needle into the blood vessel and the needle is withdrawn. An intravascular sheath of variable size is then advanced over the guidewire, percutaneously, into the lumen of the blood vessel. The introducer sheath is then used as an ingress/egress means during the procedure. Following completion of the procedure, the introducer sheath may be removed, but this requires the application of prolonged manual pressure over the puncture site by a physician or other suitably trained medical personnel. The time involved here is frequently extensive since patients are often treated with a variety of anticoagulant and thrombolytic agents, particularly in the setting of a heart attack. Alternatively, the sheath may be left in the puncture site for a prolonged period of time until the patient's coagulation status has returned to normal. Depending on the size of the vascular sheath, there may be an increased risk of bleeding to the patient, which may require blood transfusion. In addition, there is a significant risk for injury to the blood vessel upon removal of the sheath, particularly if the sheath has been in place for a prolonged period of time. This includes the possible development of an pseudo-aneurysm or severe hematoma. The current technique for removal of introducer sheaths is also painful to the patient and requires prolonged bed rest after removal. This adds to the discomfort for the patient, as well as prolonging hospitalization and costs.
Many of the intra-vascular procedures are performed in patients who are clinically unstable or who have the potential to become so, following completion of the procedure. Following removal of the vascular access sheath, it could be cumbersome and sometimes difficult to re-enter the blood vessel if necessary. Thus, with the current technique for removal of the sheath following the procedure, no easy, reliable method is available to allow reaccess to the lumen of the blood vessel, if necessary.
The prior art includes U.S. Pat. No. 4,744,364 to Kensey, U.S. Pat. No. 4,852,568 to Kensey, and U.S. Pat. No. 4,890,612 to Kensey, which disclose a method and device for sealing punctures in blood vessels by injection of a resorbable hemostatic plug into the puncture site. These devices and methods have a number of shortcomings and problems. U.S. Pat. No. 5,383,896 to Gershony et al. discloses a vascular sealing device having a thin conduit with a balloon at a distal end and an elastomeric seal at a proximal end.
Despite the need for a device and method in the art which overcomes the limitations and problems of the prior art, none insofar as is known has been proposed or developed.